Collagen is the main structural component in mammals and constitutes a large proportion of the total protein content of the skin and other body areas. Numerous trauma events in the skin, such as burns, surgery, infections and accidents, are frequently characterized by an abnormal accumulation of fibrous tissue rich in collagen and by a high content in proteoglycans. In addition to act repairing normal tissue that has been destroyed or damaged, Collagen also accumulates abnormally forming fibers, scars and cords that in certain conditions may produce some malformations (contractures, retractable scars). Excess of collagen has been attributed to an unbalance between synthesis and degradation of collagen.
Numerous diseases and pathologies are associated with deposits of excess of collagen and abnormal accumulation of fibrous tissue rich in collagen. Such diseases and pathologic conditions have been named collectively as “diseases involving alterations of collagen”. Collagenases have been used to treat such disorders involving alterations of collagen.
Collagenases are proteolytic enzymes that bind and cut specifically to sequences containing amino acids Pro-X-Gly-Pro, where X is usually a neutral amino acid. These sequences are frequently found in collagen and very rarely found in other proteins, explaining the high substrate specificity of these enzymes. Additionally, as other enzymes are able to degrade denatured collagen, collagenases are the only enzymes able to specifically recognize native collagen and hydrolyze it (Seifter y Harper, 1970. Methods Enzymol. 19, 613-635; Harper, 1980. Ann. Rev. Biochem. 49, 1063-1078; Peterkofsky 1982. Methods Enzymol. 82, 453-471).
Nowadays, treatment of the diseases related to collagen is performed by using a combination of collagenase G and H in a 1:1 ratio, such enzymes are produced by fermentation of Clostridium histolyticum and chromatographically purified, (WO2007/089851A3). Some of such diseases related to aberrant accumulation of collagen are Dupuytren's disease (US005589171A) and ophthalmic diseases (U.S. Pat. No. 4,174,389).
In all cases, the utilization of these enzymes is presented as a mixture of Collagenases (Col I and Col II or Col G and Col H). This is because until today, the procedures to obtain these enzymes have been by purification from total cell culture supernatant or milieu form Clostridium histolyticum fermentation. In the total culture milieu of such fermentations both ColG and ColH are obtained at the same time in a proportion 1:1. In further steps of purification using chromatography a mixture of both enzymes ColG and ColH is obtained in order to be used as a drug, such is the case of Xiaflex, the first medicament based on collagenases that has been approved by the FDA to treat Dupuytren's contracture.
Xiaflex is presented as a lyophilized powder, which needs to be reconstituted in a solvent just prior to its utilization. The dose is 0.58 mg by injection in a palpable metacarpophalangeal or intraphalangeal cords, administered every 2 hours into 3 slightly different positions within the cord, up to 3 times per cord at 4 week intervals.
Xiaflex contains Collagenase AUX-I and Collagenase AUX-II, isolated and purified from Clostridium histolyticum fermentation milieu.
Collagenase AUX-I is a single chain of amino acids with observed molecular weight of 114 Kilo Daltons (kDa). It belongs to class I collagenases from Clostridium histolyticum. 
Collagenase AUX-II is a single chain polypeptide with an observed molecular weight of 113 kDa. It belongs to class II collagenases from Clostridium histolyticum. 
These treatments, however, have limitations derived from the nature of the final product (an aqueous solution of reconstituted collagenases AUXI and AUXII), the source of these enzymes (C. hystoliticum) and the combination of these collagenases G and H in a proportion 1:1. All these factors make of the current medicament a product whose activity is difficult to control, also due to the way it is released in the affected area, being its main secondary effects:                1. Normal tendon rupture in the area of treatment.        2. Serious damage in the ligaments of the fingers to be treated.        3. Allergic reactions derived from the penetration of the product into the blood stream.        4. Coagulation problems derived from the disruption of the basal membranes of blood vessels.        5. CRPS (complex regional pain syndrome),        6. Peripheral edema.        7. Pain and bruises.        
These secondary effects are derived mainly from the invasion into the surrounding areas of the injection of an aqueous solution of collagenases. The aqueous solution once injected, could diffuse freely to adjacent areas producing the degradation of healthy tendons, producing immobility of joints and even reaching up to the rupture of healthy tendons and the rupture of nearby blood vessels, creating internal hemorrhagic events that are painful to the patient and invasion of the pharmacological product into the blood flow, producing important allergic reactions.
It is necessary therefore, to find a medicament, another pharmaceutical alternative that would allow obtaining the same results without the secondary effects observed with the current medicaments.